ANDA 078184

INVAGEN PHARMS

FDA Drug Application

Application #078184

Documents

• Other Important Information from FDA: 2007-09-24

Application Sponsors

ANDA 078184

INVAGEN PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET;ORAL	5MG	0	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE
002	TABLET;ORAL	10MG	0	ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE

FDA Submissions

	ORIG	1	AP	2007-09-07
LABELING; Labeling	SUPPL	2	AP	2008-09-03
LABELING; Labeling	SUPPL	5	AP	2020-06-22	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-10-26	STANDARD

Submissions Property Types

SUPPL	5	Null	15
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

INVAGEN PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 78184
            [companyName] => INVAGEN PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLPIDEM TARTRATE","activeIngredients":"ZOLPIDEM TARTRATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ZOLPIDEM TARTRATE","submission":"ZOLPIDEM TARTRATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"ZOLPIDEM TARTRATE","submission":"ZOLPIDEM TARTRATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)